SIST EN 1060-1:2000+A2:2010
(Main)Non-invasive sphygmomanometers - Part 1: General requirements
Non-invasive sphygmomanometers - Part 1: General requirements
This Part of this European Standard specifies general requirements for non-invasive sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure. It specifies performance, efficiency, mechanical and electrical safety requirements for these devices and gives test methods.
Nichtinvasive Blutdruckmeßgeräte - Teil 1: Allgemeine Anforderungen
Diese Europäische Norm legt allgemeine Anforderungen für nichtinvasive Blutdruckmessgeräte und deren
Zubehör fest, die zur nichtinvasiven Messung des arteriellen Blutdrucks mit Hilfe einer aufblasbaren
Manschette dienen.
Sie legt Anforderungen hinsichtlich der Gebrauchstauglichkeit, Messsicherheit, mechanischen und
elektrischen Sicherheit dieser Geräte fest sowie deren Prüfverfahren.
ANMERKUNG Diese Norm empfiehlt, verriegelbare Luer-Anschlussstücke bei diesen Geräten nicht zu verwenden.
Tensiomètres non invasifs - Partie 1: Exigences générales
Cette partie de la norme européenne prescrit les exigences générales des tensiomètres non invasifs et de leurs
accessoires qui, à l'aide d'un brassard gonflable, sont utilisés pour la mesure non invasive de la pression artérielle.
Elle prescrit les exigences de performance, d'efficacité et de sécurité mécanique et électrique de ces dispositifs,
et décrit les méthodes d'essai.
NOTE Cette norme européenne recommande de ne pas utiliser les raccords Luer avec ces dispositifs.
Neinvazivni sfigmomanometri - 1. del: Splošne zahteve
Ta del tega evropskega standarda določa splošne zahteve za neinvazivne sfigmomanometre in njihove dodatke, ki se s pomočjo napihljive manšete uporabljajo za neinvazivno merjenje arterijskega krvnega tlaka. Določa zahteve za zmogljivost, učinkovitost, mehansko in električno varnost za te pripomočke in podaja preskusne metode.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neinvazivni sfigmomanometri - 1. del: Splošne zahteveNichtinvasive Blutdruckmeßgeräte - Teil 1: Allgemeine AnforderungenTensiomètres non invasifs - Partie 1: Exigences généralesNon-invasive sphygmomanometers - Part 1: General requirements11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 1060-1:1995+A2:2009SIST EN 1060-1:2000+A2:2010en,fr,de01-marec-2010SIST EN 1060-1:2000+A2:2010SLOVENSKI
STANDARD
SIST EN 1060-1:2000+A2:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1060-1:1995+A2
December 2009 ICS 11.040.55 Supersedes EN 1060-1:1995English Version
Non-invasive sphygmomanometers - Part 1: General requirements
Tensiomètres non invasifs - Partie 1: Exigences générales Nichtinvasive Blutdruckmessgeräte - Teil 1: Allgemeine Anforderungen This European Standard was approved by CEN on 14 April 1995 and includes Amendment 1 approved by CEN on 6 April 2002 and Amendment 2 approved by CEN on 15 November 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1060-1:1995+A2:2009: ESIST EN 1060-1:2000+A2:2010
EN 1060-1:1995+A2:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Definitions .44Cuff .55Display .56Units .57Requirements .68Test methods .69Information supplied by the manufacturer .9Annex ZA (informative)
#Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices$ . 11 SIST EN 1060-1:2000+A2:2010
EN 1060-1:1995+A2:2009 (E) 3 Foreword This document has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. The European Standard "non-invasive sphygmomanometers" consists of the following parts: Part 1: General requirements Part 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems #deleted text$ #Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers$ This European Standard shall be given the status of a National Standard, either by publication of an identical text or by endorsement, at the latest by June 2010, and conflicting national standards shall be withdrawn at the latest by June 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2002-04-06 and Amendment 2, approved by CEN on 2009-11-15. This document supersedes EN 1060-1:1995. The start and finish of text introduced or altered by amendment is indicated in the text by tags!"
and # $This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directives, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
SIST EN 1060-1:2000+A2:2010
EN 1060-1:1995+A2:2009 (E) 4 1 Scope This Part of this European Standard specifies general requirements for non-invasive sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure. It specifies performance, efficiency, mechanical and electrical safety requirements for these devices and gives test methods. NOTE This standard recommends that Luer lock connectors should not be used with these devices. 2 Normative references #The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.$ EN 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety #EN 980, Symbols for use in the labelling of medical devices$ #EN 1041, Information supplied by the manufacturer of medical devices$ 3 Definitions For the purposes of this Part of EN 1060, the following definitions apply. 3.1 bladder inflatable component of the cuff 3.2 blood pressure pressure in the arterial system of the body 3.3 cuff component of the sphygmomanometer, usually comprising a bladder and a sleeve, that is wrapped around the limb of the patient 3.4 diastolic blood pressure (value) minimum value of the arterial blood pressure as a result of relaxation of the left ventricle NOTE Because of hydrostatic effects, this value should be measured with the cuff at the heart level. 3.5 mean arterial blood pressure (value) value of the integral of one cycle of the blood pressure curve divided by the time of one heart beat period NOTE Because of hydrostatic effects, this value should be measured with the cuff at the heart level. 3.6 non-invasive blood pressure measurement indirect measurement of the arterial blood pressure without arterial puncture SIST EN 1060-1:2000+A2:2010
EN 1060-1:1995+A2:2009 (E) 5 3.7 pneumatic system system that includes all pressurised and pressure-controlling parts such as cuff, tubing, connectors, valves, transducer and pump 3.8 sleeve essentially inelastic part of the cuff that encloses the bladder 3.9 sphygmomanometer instrument used for non-invasive measurement of the arterial blood pressure 3.10 systolic blood pressure (value) maximum value of the arterial blood pressure as a result of the contraction of the left ventricle NOTE Because of hydrostatic effects, this value should be measured with the cuff at the heart level 4 Cuff The cuff shall contain a bladder. For reusable cuffs the manufacturer shall indicate the method for cleaning in the accompanying documents (see 9.2). NOTE The optimum bladder size is one with dimensions such that its width is 40 % of the limb circumference at the centre of the range for each cuff size and that its length is 80 % to 100 % of the limb circumference at the centre of the range for each cuff size. Use of the wrong size can affect the accuracy of the measurement. These
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